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标题: 20151022 ECA新闻:修订后的USP通论<661>容器---塑料 [打印本页]
作者: 淡定 时间: 2015-10-29 11:55 AM
标题: 20151022 ECA新闻:修订后的USP通论<661>容器---塑料
20151022 ECA新闻:修订后的USP通论<661>容器---塑料GMP News
22/10/2015
Revised USP General Chapter <661> Containers-Plastics
修订后的USP通论<661>容器---塑料
The revised USP General Chapter <661> (Containers-Plastics) will be published in USP 39-NF34 with an official date of May 1, 2016.
修订后的USP通论<661>(容器-塑料)将在USP39-NF34中出版,生效日期为2016年5月1日。
Including Changes to the title of General Chapter <661> (new title: Plastic Pckaging Systems and their Materials of Construction), sections of General Chapter <661> moved into new General Chapters <661.1> (Plastic Materials of Construction) and <661.2> (Plastic Packaging Systems for Pharmaceutical Use). The General Chapter <661.1> gives information on the comprehensive characterization of a plastic material, while General Chapter <661.2> covers testing methods and standards for packaging systems made of plastic.
变更包括通论<661>标题的变更(新标题:塑料包装系统和其构成原料),通论所在位置移到了新的通论<661.1>(塑料原料)和<661.2>(药用塑料包装系统)。通论<661.1>里给出了关于塑料物料的综合定性信息,而通论<661.2>里则包括了塑料制包装系统的测试方法和标准。
The Drafts of the above mentioned General Chapters were proposed for comment in Pharmacopeial Forum 39(5) and 40(5).
上述通论的草案是在药典论坛39(5)和40(5)上公开征求意见的。
All modifications will become official on May 1, 2016.
所有修订都将于2016年5月1日正式生效。
Additionally, a Draft of a new USP General Chapter <1661> (Evaluation of Plastic Packaging Systems and their Materials of Construction with respect to their user safety impact) was proposed in Pharmacopeial Forum 40(6).
另外,又新起草了一份USP通论<1661>(塑料包装系统及其结构材料对其使用安全的影响)在药典论坛40(6)上公开。
在注册USP药典论坛后,你就能获得完整的<661><661.1><661.2>和<1661>草案。
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